Novel Approaches to Sleep Difficulties: Application in Mild TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- PSQI Change
研究概览
简要总结
Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design: Randomized, blinded, sham-controlled clinical trial Setting: Outpatient clinic at a major VA medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups, real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M).
Intervention: Real or sham acupuncture with both standardized and individualized acupoints selection. All subjects were informed that the treatments, if effective, may improve symptoms such as pain, anxiety or depression other than sleep; real acupuncture may not be effective in some individuals, and sham acupuncture may as well be effective by mind-body interactions.
Outcome Measures: Primary outcome measure was global PSQI score change after intervention as compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a co-variant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 55; and,
- •Meeting the diagnosis criteria for mild traumatic brain injury as listed above at the time of injury; and,
- •At or over 3 months post injury; and,
- •With untreated sleep complaints (Pittsburgh Sleep Quality Index [PSQI] > 8, sleep difficulties at least 4x per week in the past month, average sleep duration of 6 hours or less); and,
- •Has the capacity to give informed consent.
- •Agree to attend 13 clinic visits
排除标准
- •Same sleep complaints present prior to traumatic brain injury; or,
- •Diagnosis of obstructive sleep apnea (OSA) by prior sleep study; or,
- •With a non-daytime work-schedule; or,
- •With prior acupuncture experience for the treatment of sleep difficulties or with acupuncture treatment within 3 months; or,
- •History of bleeding diathesis or currently on anticoagulation with international normalized ratio (INR) over 2.5; or,
- •Severe depression with Beck Depression Score of 29 and above; or,
- •Moderate and severe alcohol users.
- •Does not have a permanent address
结局指标
主要结局
PSQI Change
时间窗: Baseline and post-intervention
change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The PSQI global score has a possible range of 0-21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition.
次要结局
- Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency(pre-intervention, post-intervention (1wk of recording each))